Davita Harper Wood Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 27408 Based on observation, interview, and record review, the facility failed to maintain a sanitary environment resulting in the potential for the spread of infectious disease amongst the 47 patients receiving dialysis treatment at the facility. Findings include: 1. The facility failed to provide a sanitary environment. (see tag V-111) 2. The facility failed to ensure designated clean areas were only utilized for clean and unused equipment, supplies, and medications. (see tag V-117) 3. The facility failed to disinfect dialysis stations after treatments. (see tag V-122) 4. The facility failed to ensure expired medications were not available for use. (see tag V-143)”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 45246 Based on interview and record review, the facility failed to maintain an effective, data-driven quality program that effectively covered the scope and complexity of all areas of the dialysis facility, resulting in the potential for unmet patient needs and poor patient outcomes. Findings include: See specific tags: V-627 Failure to develop and maintain a quality improvement plan. V-638 Failure to continuously monitor facility performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time.”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 22960 Based on interview and record review, the facility failed to conduct the annual tabletop and community-based emergency preparedness trainings, resulting in the potential for inadequate facility response during an emergency event, endangering the health and safety of all patients and staff. Findings include: On 1/8/25 at 1:30 PM, the facility’s Emergency Preparedness Plan was reviewed with Facility Administrator (FA) “E”. There was no documentation of a full-scale community exercise, or communication with a local jurisdiction stating that they would excuse the facility’s participation in the community-based exercise. There was an undated sign-in sheet that noted “Severe Weather Table Top” and an undated sign-in sheet that noted “Shelter-in-Place Table Top”, There was no documentation of an emergency scenario with a set of problem statements and questions designed to challenge the emergency plan, no analysis of the facility’s response and any revision to the facility’s emergency plan if needed. FA “E” stated that any table top drills should be documented on their template, and confirmed there were none in the Emergency Plan binder. Review of the Facility Emergency Management Plan reviewed 8/14/24 noted under Training and Education: “e. Frequency: i. The facility will conduct and/or participate in one (1) exercise to test the facility EMP at least ANNUALLY, conducted on OPPOSITE years...1. Full scale exercise that is community based...2. Individual facility-based exercise: a. Tabletop exercise that includes a group discussion led by the FA...i. Documentation is required 1. Utilize Facility Emergency Plan Activation template and document...ii. Maintain copy with facility EMP.””

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 50585 Based on observation, interview and record review, the facility failed to provide and maintain a safe and sanitary environmnet resulting in potential for infection transmission and negative outcomes to the 24 patients receiving treatment at the time of observations. Findings include: On 1/7/2025 at 1305, during a tour of the facility’s treatment area and water room, the following observations were noted: - One corrugated cardboard box of medical supplies with a shipping label on the outside of the box (dirty) was observed stored on a counter next to a sink labeled as clean. - A wet/dry vacuum was observed on the floor next to an eye wash station and a sink and the vacuum’s hose (dirty) was placed where the hose was in contact with an eye wash station (clean) and the sink labeled as clean. - Nine intravenous (IV) bags of 0.9% Sodium Chloride 1,000 milliliter (mL) solution were observed hanging on an IV pole at 9 different patient care stations. All 9 bags were outside of the the plastic over wrap thereby exposing the IV entry point. - One IV bag of 0.9% Sodium Chloride, 500 mL was observed on the shelf behind the clean supply cart in the facility’s treatment area with the plastic over wrap removed from the IV bag exposing the IV entry point. - Four patient dialysis treatment chairs (Stations 8, 18, 23, and 24) were observed to have torn fabric. - Five stained ceiling tiles were observed in the storage room next to the water room. Clinical Nurse Manager Staff A confirmed the findings at the time of discovery. 27408 On 01/08/25 at 1010, during tour of the facility treatment area, debris (candy wrappers, white cloths, plastic tips and a used tissue) were observed to be on the dialysis floor throughout the unit. Additionally, white cloths (used to wipe down the dialysis stations) that appeared to be wet and saturated, were in the middle of the pathway that lead of the treatment floor. 45246 During initial tour of the facility on 01/07/25 from 1310 to approximately 1400 treatment floor area was observed for cleanliness, medications and supplies storage. The following supplies/medications were found expired: two blood culture kits expired 11/22/24, 25 clear top vacutainers expired on 5/31/24, 5 1 liter bags of NaCl 0.9% (Normal Saline) expired August 2024. Clinical Nurse Manager, Staff A, was present during the tour and was asked if expired supplies should be discarded by staff. Staff A stated “yes”. Wall boxes for stations # 7, 8, 17, 18, 24 and isolation room had large amount of white solidified/crystallized sediment in them. Staff C, biomedical technician, who was present during observation, was asked who is responsible to clean wall boxes. Staff C said that clinical staff are responsible to clean wall boxes after each treatment and monitor for sediment build up. Isolation room had a part of the dry wall, next to the patient’s treatment chair, exposed with paint scratched off. Plastic windowsill edge was torn off (placed on the window) and had compressed particle board exposed. Overhead storage cabinet had a laminate piece torn off, hanging, and cabinet particle board exposed. Window behind station #24 had dry wall on top of it missing with area about 5 x 5 inches exposed. Blue plastic was observed under the missing drywall. Air vent next to station #9 was found with dark gray sediments and dust visible that was moving with air flow. Staff A and Staff B confirmed the findings. Facility’s policy “Infection Control for Dialysis Facilities”, dated April 2023, was reviewed and revealed: “Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. Supplies. 8. Supplies will be stored in a manner that maintains their integrity. a. Patient and visitors should not access the supplies. b. Expiration date and package integrity will be verified prior to use. c. Supplies will not be opened until time of use. d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet or contaminated, the package and its contents must be disposed of and not used. 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system. Pressurized washers, spray bottles, or sprayers for cleaning purposes will not be used on wall boxes or the adjoining area. Teammates will monitor and address wall box residue/build up and patency issues.” Facility’s policy “Physical Environment”, dated April 2018, revealed: “Purpose: To provide guidance on the physical environment of dialysis facility and treatment area. Policy: 1. The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. 2. The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates and the public. 5. The space for treating each patient will be sufficient to provide needed care and services, prevent cross contamination, and to accommodate medical emergency equipment and teammates.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 27408 Based on observation, interview, and record review, the facility failed to ensure clean supplies were not mixed with dirty materials, resulting in the potential for the spread of infection to all 24 patients receiving dialysis treatment at the facility at the time of observation. Findings include: On 01/08/25 at 1010, Patient Care Technician (PCT), Staff K, was discarding contaminated blood line from station #14 and carried them to the biohazardous receptacle. She then proceeded with the same gloves (contaminated) and went to the “Technician Clean Supply Cart” where she grabbed a stack of the white cloths, dipped them in the chlorine solution (used to clean the dialysis stations, etc..) and then use the cloths to clean station #14. On 01/08/25 at 1012, Staff K was queried as to what the process would be for discarding bloodlines then gathering clean supplies. Staff K stated “I guess I should’ve changed my gloves”. On 01/09/25 at 1100, review of the facility policy titled “Infection Control for Dialysis Facilities, #1-05-01, dated October 2021” documented, “44. Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility staff failed to disinfect the patient’s entire dialysis machine and surrounding surfaces following a patient’s treatment for 5 of 5 station cleanings observed, resulting in the potential for the spread of infectious agents to the patients at the 5 stations observed. Findings include: On 1/9/2024 at 1030, Technician Staff J was observed at station 11 cleaning the dialysis machine following a patient’s dialysis. During observation, Staff J failed to disinfect the counter behind the dialysis machine. When queried whether the counter behind the dialysis machine should be cleaned, Staff J replied “do I have to?” When queried what the facility’s policy revealed, Staff J proceeded to clean and disinfect the back counter. 45246 During patient care observations on 01/08/25 at 1050, registered nurse, Staff O, was observed cleaning station #1. Nurse was observed wiping clean the treatment chair and closed both chair wings right after wiping, and not allowing them to fully dry. Further, Staff O did not wipe the back ledge where patients store their belongings. Later, at 1100, dialysis technician, Staff N, was observed cleaning station #3. Staff N wiped the patient chair and closed the chair wings right away, without air drying them. 27408 On 01/08/25 at 1043, Staff J was observed disinfecting station #9. Staff J failed to disinfect the back shelf at the station, and failed to clean the reusable patient blood pressure cuff when removing it from the contaminated chair. On 01/08/25 at 1055, Staff J was queried about these observations, and she verified that she hadn’t cleaned the shelf but thought she wiped blood pressure cuff. Also, on 01/08/25 at 1100, Staff K was observed disinfecting station #14. Staff K failed to disinfect the station’s back shelf. On 01/08/25 at approximately 1115, Staff K was queried about and verified these observations. Staff K also stated that she was a new employee, and was still in training. According to the facility’s policy “Infection Control for Dialysis Facilities,” dated 4/2023, “At the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings, (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel, top, front, and sides of dialysis machine, touchstones, countertops). Disinfection. b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. ii. Sufficient disinfectant should be applied so that surfaces are visibly wet. iii. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time.””

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility failed to follow national guidelines for assigning expiration dates after multi-dose vials of injectable medications were accessed for 2 of 2 medications resulting in the potential for negative outcomes for the 24 patients receiving treatment at the time of observation. Findings include: On 1/7/2025 at 1000, during a tour of the facility’s treatment program, two vials of heparin for injection, 1,000 units/milliliter, 30 mL vials were observed in the top drawer of the counter where the medications were stored. The two vials were previously accessed and both vials were labeled with a handwritten expiration date of 5/31/2026. The manufacturer’s expiration dates for both vials were also 5/31/2026. Clinical Nurse Manager Staff A confirmed the findings of the incorrect expiration dates on the open heparin vials at the time of discovery. On 1/9/2025 at 1230, Chief Medical Officer Staff F, was interviewed and was asked if they expected staff to follow all policies and procedures, and they said “absolutely, 100%.” According to the facility’s policy “Medication,” dated 11/2023, “Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date or as directed by the manufacturer as in the case of vaccines or state specific pharmacy regulations. Each vial is labeled with the initials of the person opening the vial and the expiration date.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility staff failed to independently test for pH and conductivity of a patient’s dialysate for 2 of 2 patients observed, resulting in the potential for negative outcomes for the two patients. Findings include: On 1/8/2025 at 1045, Technician Staff L was observed setting up the dialysis machine for P-3. Staff L was observed connecting the dialysis lines to P-3 and initiating blood flow through the dialysis machine. After the lines were established, Staff L was asked if they completed the independent pH and conductivity testing and they stated “no.” On 1/9/2025 at 1230, Chief Medical Officer Staff L was asked if they expected staff to follow the facility’s policies and procedures and they said “absolutely, 100%.” 45246 On 01/08/25 at 1055 Patient Care technician, Staff I, was observed initiating dialysis treatment for the patient at station #2. Staff I was observed not testing pH and conductivity prior to initiating the dialysis treatment. Staff I was interviewed on 01/08/25 at 1425. He was queried regarding machine testing process prior to connecting patients to the dialysis machines. Staff I was able to verbalize the testing process. When asked if he tested water for pH and conductivity prior to initiating dialysis for patient at station #2 earlier that day, he stated “no, I forgot”. On 01/07/25 at 0920 Biomed technician, Staff C, confirmed that dialysis machines in use at the facility (Fresenius 2008K) had no preset functions to test for pH and conductivity. It was the clinical staff responsibility to test dialysate prior to each patient treatment. According to the facility’s policy “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate., dated 10/2024, “Manual pH testing must be performed prior to each patient treatment” and “Trained teammates will test pH and if applicable, conductivity of final dialysate utilizing appropriate test strips and/or meters prior to each patient treatment and/or when changing the acid concentrate formulations or bicarbonate container during the course of a treatment.””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 22960 Based on interview and record review, the facility failed to document bicarbonate mixing conductivity test results, and failed to address test results that were out of range. Findings include: Review of the facility logs “Bicarb Mix Log-Conductivity with Myron-L 4P or 6P Meter” on 1/8/25 at 10:00 AM revealed the following: There were “holes” (no values recorded) for the Bicarb mixing tank conductivity test results and the Bicarb return loop conductivity test results on the following dates: 8/30/24 (0450, 0600 and 0900), 9/6/24, 11/11/24, 12/2/24, 12/4/24, 12/11/24, and 1/3/25. In addition, on 11/11/24, there was no signature of the preparer or second teammate signature verification. On 11/14/24, 11/15/24, 11/27/24 and 12/30/24, there were no documented signatures for the second teammate verification. Further review at that time, revealed on 10/14/24, 10/21/24, 10/23/24, 10/25/24, 10/28/24, 11/25/24, 11/29/24, 12/16/24, 12/18/24 and 12/30/24, there were conductivity values logged that were out of range, but no documentation for corrective actions for these out of ranges test results. On 1/8/25 at 11:00 AM, when queried about the bicarbonate mixing logs, Biomed staff “C” stated that if the levels are too high, that the bicarbonate should be re-mixed. Biomed staff “C” confirmed the “holes” in the bicarbonate logs, but provided no further explanation. Review of the policy “Bicarb Concentrate Conductivity Batch Testing” dated 1-20-12 noted: “4. Bicarb conductivity batch testing is performed to verify final bicarb concentrate quality of each batch prepared...6. For central delivery bicarb systems, two (2) collection sample sites must be identified and labeled as follows: a. The first site is the outlet of the mixing tank prior to entry into distribution system. b. The second site is the return to the end of distribution loop where it enters the distribution tank...If calibration of the meter is not within acceptable range, contact Biomed...9. The bicarb concentrate conductivity reading should be within acceptable range. Acceptable conductivity range is 48-52 mS...11. If results are unacceptable, re-test. If second result is unacceptable, discard bicarb concentrate batch. Unacceptable test results indicate bicarb concentrate is improperly mixed and batch should be discarded.””

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 45246 Based on the interview and record review, the facility failed to develop and maintain an ongoing quality improvement plan as part of quality assessment and performance improvement program (QAPI) for measures of water and dialysate quality and safety, resulting in the potential for negative patient outcomes. Findings include: During the survey on 01/08/25 two observations were made regarding staff failure to test for dialysate pH and conductivity prior to patients’ treatments. On 01/09/25 at 1255 during QAPI discussion with Clinical Nurse Managers, Staff A and Staff B, audits of documentation and process improvement plan regarding the staff compliance with testing dialysate for pH and conductivity prior to every treatment were requested for review. No documentation was provided to support the ongoing audit process and the process improvement plan based on results of the audits in place to address/maintain staff compliance. Review of the previous survey conducted in the facility on 02/15/23 revealed that the facility failed to consistently assure water quality and test for dialysate conductivity and pH prior to patients’ treatments. During interview with facility Medical Director, Staff F, on 01/09/25 at 1220 he stated that he was aware that facility had identified opportunities with water testing during previous survey and was expecting staff to continue with improvement process.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 45246 Based on interview and record review, the facility failed to continuously monitor its performance regarding all necessary water testing and infection control and prevention, take actions that resulted in performance improvements, and fialed to track performance to ensure that improvements are sustained over time, resulting in the potential for adverse patient outcomes for all patients served by the facility. Findings include: During the QAPI (quality assurance performance improvement) interview with Clinical Nurse Managers, Staff A and Staff B, on 01/09/25 at 1255, review was completed of multiple facility concerns, including but not limited to infection prevention and control, physical environment, water and dialysate quality as well as discussions of performance improvement plans. Staff B explained that facility administrator, Staff E, who was not present in a facility during survey, was a newer staff in this role (since 08/26/24). Staff B recognized the evident lack of documentation for QAPI process improvement plans, audits and evaluations. Review of provided “Monthly Infection Control Audits” revealed 9 months of audits with other 3 months missing (01/24, 07/24 and 08/24). Review of the last quarter of 2024 audits data revealed that question #10 “All medications, medical treatment supplies, and lab supplies are not expired” was answered as “yes” for the months of October, November and December 2024. During survey, on 01/08/25, multiple supplies were found expires in a facility (blood culture kits expired on 11/22/24, 25 clear top vacutainers expired on 5/31/24, 5 bags on Normal Saline solution expired August 2024). Further review of the infection control audits revealed question #16 “water boxes clean and damage free” answered as “yes” on October audit. Question #16 was not present (audited) in November and December audits. Moreover, audits for November and December had observations of station cleaning by staff with “wall boxes cleaned” marked as “yes”. During facility tour and observations on 01/08/25 multiple wall boxes (stations # 7, 8, 17, 18, 24 and isolation room) were found with large amount of white hardened sediment on them, not cleaned by staff. Facility’s QAPI minutes were requested for review. Minutes for six months were provided (from June to November 2024). QAPI minutes for months of January 2024 to May 2024 were not available for review. During interview with facility Medical Director, Staff F, on 01/09/25 at 1220 he was asked if his expectation was for staff to follow facility’s policies and procedures. Staff F stated “yes”. Review of the facility policy “Continuous Quality Improvement Program”, revised 04/2021, revealed: “Purpose: To improve patient safety and outcomes including the reduction of medical errors in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in the CMS Conditions for Coverage. Policy: 2. Facility Administrators (FAs) conduct periodic Facility Health Meetings (FHM) (also known as QAPI in the CMS Conditions for Coverage) with the CQI committee to review issues and indicators regarding facility’s management and performance. FHMs are conducted monthly. 4. The Facility Medical Director is responsible for verifying the execution as well as participation in the Quality Improvement Program including implementation, continuous monitoring, development of action plans and program evaluation. 7. The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: -Patient Safety -Infection Control 8. Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility’s Medical Director failed to ensure staff followed policies and procedures for removing outdated medications and supplies from storage areas and for preparing medications for administration for 2 of 2 storage areas observed resulting in the potential for less-than-optimal outcomes for all patients. Findings include: On 1/7/2025 at 1305 to 1400, during a tour of the facility’s dialysis treatment area, the following expired medications and supplies were observed. In the medication drawer, one bottle of acetaminophen tabs, 325 milligram (mg) with an expiration date 4/2024, one vial of vancomycin 500 mg for injection with an expiration date 5/2024, and one vial of diphenhydramine injection 50 mg / milliliter with an expiration date 10/2024 were observed. In the medical supply cart, three green vacutainer blood collection tubes with expiration dates 12/31/2024 and one yellow vacutainer blood collection tube with expiration date 11/30/2024 were observed. Clinical Nurse Manager (CNM) Staff A confirmed the expired medications and supplies were present in the drawer at the time of discovery. On 1/7/2025 at 1345, during inspection of the medication refrigerator, an injectable syringe containing 2.5 milliliters of a dark substance was observed on the shelf of the medication refrigerator. The syrigne was capped and had a label that revealed “Venofer” and there was no expiration noted on the label. CNM Staff A confirmed the findings of the medication drawn up in a syringe at the time of discovery. On 1/8/2025 at 0945, P-6 was observed receiving a dialysis treatment on machine #21 at station 2. P-6’s dialysis monitor screen was observed and the Dialysis Flow Rate (DFR) displayed was 600 mL/minute. Technician Staff L approached and revealed that there were problems with machine 21, and they were running the DFR at a maximum rate of “600 mL/minute.” According the P-6’s treatment detail sheet, the order for P-6’s DFR was 800 mL/minute. Staff L was asked for how long has machine #21 been faulty, and they said for a “few months.” Additional patient treatment sheets for P-6 were reviewed and on 1/6/2025 from 0602 to 0930 and 1/3/2025 from 0547 to 0919, P-6’s ordered DFR was 800 mL/minute and the average DRF during P-6’s treatments was 600 mL/minute. The DFR remained at 600 mL/minute for both treatments. Nurse Staff O attested on both treatments detail sheets for 1/3/2025 and 1/6/2025 that “I verify that the patients presription matches what is currently being delivered during the dialsysis treatment.” On 1/6/2025 from 1202 to 1549, P-7’s treatment detail sheets revealed that P-7 was on machine #21 at station 2 and had an ordered DFR of 800 mL/minute. The average DFR reported was 600 mL/minute and the DFR remained at 600 mL/hour for the entire treatment. On 1/6/25, Charge Nurse Staff M attested “I verify that the patients presription matches what is currently being delivered during the dialsysis treatment.” On 1/9/2024 at 1250, Regional Manager of Biomedical Engineering Staff D was interviewed about the process for reporting machines that were not working correctly. Staff D revealed that the machine should have been removed from service and revealed that the facility has “three back up machines” that may be used if needed. According to the facility’s policy “Medication,” dated 11/2023, “All medications in the facility are checked monthly. Insulin and other medications with preservative area dated and initialed once opened. All medications are checked monthly for expiration dates” and Medications are ordered and replaced prior toe expiration. Unless an exact expiration date is specified, medications with an expiration date of month/year are considered expired the last day of the state month. For example, a drug that expires 6/08 will be considered expired after 6/30/08.” The policy also revealed that “All syringes prepared from single use vials/ampoules (without preventives or multidose vials should be prepared and administered unless there is specific testing and documents on file which extends dating” and “Medications are stored in the original vial and are not drawn up and stored overnight in a syringe or any other container.””

“GOV-ADM RESP FOR RESOURCES FOR QAPI CFR(s): 494.180(a)(4) The governing body or designated person responsible must appoint an individual who serves as the dialysis facility’s chief executive officer or administrator who exercises responsibility for the management of the facility and the provision of all dialysis services, including, but not limited to- (4) Allocation of necessary staff and other resources for the facility’s quality assessment and performance improvement program as described in §494.110. This Standard is not met as evidenced by: 45246 Based on the interview and record review, the facility failed to provide necessary resources for the facility’s quality assessment and performance improvement program, resulting in lack of oversight and process improvement for water testing with potential for negative outcomes to all patients in the facility. Findings include: During the QAPI (quality assurance performance improvement) interview with Clinical Nurse Managers, Staff A and B, on 01/09/25 at 1255, it was identified that facility had several changes in administrators during the period of 2023-2024. Provided Governing body minutes for 2024 were reviewed and revealed no consistent communication between QAPI committee and Governing body regarding previously identified issues with water testing. No consistent documentation was provided by facility to support the ongoing process improvement to sustain compliance with all water quality testing identified by previous survey in 2023. There was no documented evidence of consistent QAPI reports to the Governing body regarding safety and survey preparedness. Furthermore, based on current survey findings, it was identified that staff is not compliant with facility’s policies and procedures for dialysate testing for pH and conductivity prior to every patient treatment. During interview with facility Medical Director, Staff F, on 01/09/25 at 1220 he stated that he was closely working with facility’s staff on identifying issues and correcting them. Staff F confirmed that he was a member of the QAPI and Governing body for the facility. When asked if he was aware of the identified during previous survey (in 2023) issues with consistency in water testing, Staff F stated “yes”. When asked how facility was addressing identified issues and sustaining compliance, Staff F shared that facility was continuously working on improvement. Governing body policy was requested. Three-page document without header and a date was provided by facility. The document indicated: “3.6. Physical Environment. The Governing Body shall: (a) Ensure that the physical environment in which ESRD facilities provide services is functional, sanitary, safe, and comfortable for patients and staff; (b) Approve, adopt and ensure compliance by the Facility, with policies that address building and equipment standards, environment for patients, contamination prevention and emergency preparedness, all in compliance with federal and state laws governing ESRD facilities.””

“GOV-INVOL DISCHARGE PROCESS REQUIREMENTS CFR(s): 494.180(f)(4) The medical director ensures that no patient is discharged or transferred from the facility unless - (4) The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. This Standard is not met as evidenced by: 50585 Based on interview and record review, the facility staff failed to document that staff assisted a patient in obtaining dialysis treatment after the patient was involuntary discharged from the facility for 1 (P-8) of 1 patient resulting in the potential for less-than-optimal outcomes for the patient. Findings include: According to the facility’s “ESRD Involuntary Discharge Report,” dated 7/19/2023, P-8 was involuntary discharged from the facility on 7/20/2023 for disruptive and intimidating behavior. Under the “Required Discharge Notifications Made by Facility” section of the report, there was no date noted under “Contacted another facility to attempt to place the patient” section. All other required fields (i.e., steps to perform) had a completion date documented. The facility’s letter to P-8, dated 7/20/2023, revealed that “A list of alternative dialysis providers and hospitals in the area is attached and you need to seek treatment at one of the following dialysis facilities or the nearest emergency room. We have contacted (facility) guest services to assist with placement. Placement is ultimately your responsibility.” The letter also revealed that “It is important that you find another dialysis clinic as as soon as possible.” On 1/9/2025 at 1240, Clinical Nurse Manager Staff B was queried if there was any documentation from the facility’s guest services department that revealed that guest services provided any assistance for placing P-8, and they said “no.””